LEMSIP MAX DAY & NIGHT COLD & FLU RELIEF CAPSULES (paracetamol, caffeine and phenylephrine hydrochloride) PL 00063/0529 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 5 Summary of Product Characteristics Page 12 Patient Information Leaflet Page 13 Labelling Page 14 Steps Taken After Authorisation - Summary Page 17 Annex 1 Page 18
LAY SUMMARY LEMSIP MAX DAY & NIGHT COLD & FLU RELIEF CAPSULES (paracetamol, caffeine and phenylephrine hydrochloride) This is a summary of the Public Assessment Report (PAR) for Lemsip Max Day & Night Cold & Flu Relief Capsules (PL 00063/0529). It explains how the application for Lemsip Max Day & Night Cold & Flu Relief Capsules was assessed and its authorisation recommended, as well as the conditions of use. It is not intended to provide practical advice on how to use Lemsip Max Day & Night Cold & Flu Relief Capsules. The product may be referred to as Lemsip Max Cold & Flu Relief Capsules in this report. For practical information about using Lemsip Max Cold & Flu Relief Capsules, patients should read the package leaflet or contact their doctor or pharmacist. What are Lemsip Max Cold & Flu Relief Capsules and what are they used for? This medicine is the same as Lemsip Max Day & Night Cold & Flu Relief Capsules (PL 00063/0143) held by Reckitt Benckiser Healthcare (UK) Limited, which is already authorised in the UK. The licence holder (Reckitt Benckiser Healthcare (UK) Limited) for Lemsip Max Day & Night Cold & Flu Relief Capsules (PL 00063/0143) has agreed that its own scientific data can be used as a basis for the grant of an identical licence for Lemsip Max Cold & Flu Relief Capsules (informed consent). Lemsip Max Cold & Flu Relief Capsules consist of two types of capsules: a red and yellow Day capsule for daytime use and a red and blue Night capsule for night time use. Lemsip Max Cold & Flu Relief Capsules contain a combination of ingredients which are effective in relieving the symptoms associated with colds and flu, including relief of aches and pains, sore throats, headache, nasal congestion and lowering of temperature. How do Lemsip Max Cold & Flu Relief Capsules work? Lemsip Cold & Flu Relief Capsules contain the active ingredients paracetamol, caffeine (Day capsule only) and phenylephrine hydrochloride. Paracetamol is a well-known painkiller (analgesic). It is effective against aches and pains, including a headache, and can also reduce a fever (antipyretic). Caffeine (a mild stimulant) helps relieve fatigue and drowsiness through the day (it is only used in the Day Capsule). Phenylephrine hydrochloride (nasal decongestant) reduces swelling in the passages of the nose, relieving nasal congestion and reducing the pressure which may cause a headache. How are Lemsip Max Cold & Flu Relief Capsules used? Lemsip Max Cold & Flu Relief Capsules are available as red and yellow capsules (to be taken during daytime) and red and blue capsules (to be taken at night time). The capsules should be taken by mouth, swallowed whole with water. It is important to drink plenty of fluids when suffering from colds and flu. Lemsip Cold & Flu Relief Capsules should not be chewed. 2
The recommended dose: Adults and children over 12 Daytime Two red and yellow capsules every 4-6 hours Maximum daytime dosage: 6 capsules Do not exceed 8 capsules in total in any 24 hours. Dose Night time Two red and blue capsules to be taken at bed time. Maximum night time dosage: 2 capsules Lemsip Max Cold & Flu Relief Capsules should not be given to children under 12 years of age. Please read section 3 of the package leaflet (PL) for detailed information on dosing recommendations, the route of administration, and the duration of treatment. Lemsip Max Cold & Flu Relief Capsules can be obtained without a prescription, at pharmacies with the supervision of a pharmacist. What benefits of Lemsip Max Cold & Flu Relief Capsules have been shown in studies? As paracetamol, caffeine and phenylephrine hydrochloride are well-known substances and their use in the licensed indications is well established, the applicant presented data from the scientific literature. The literature confirmed the efficacy and safety of paracetamol, caffeine and phenylephrine hydrochloride in the licensed indications. What are the possible side effects from Lemsip Max Cold & Flu Relief Capsules? Like all medicines, Lemsip Max Cold & Flu Relief Capsules can cause side effects, although not everybody gets them. For the full list of all side effects reported with Lemsip Max Cold & Flu Relief Capsules, see section 4 of the package leaflet or the Summary of Product Characteristics available on the MHRA website. Also, for the full list of restrictions, see the package leaflet. Why is Lemsip Max Cold & Flu Relief Capsules approved? The MHRA concluded that, in accordance with EU requirements, the benefits of Lemsip Max Cold & Flu Relief Capsules outweigh the identified risks and recommended that the product be approved for use. What measures are being taken to ensure the safe and effective use of Lemsip Max Cold & Flu Relief Capsules? Safety information has been included in the Summary of Product Characteristics and the package leaflet for Lemsip Max Cold & Flu Relief Capsules, including the appropriate precautions to be followed by healthcare professionals and patients. Known side effects are continuously monitored. Furthermore, new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously. Other information about Lemsip Max Cold & Flu Relief Capsules. A Marketing Authorisation was granted in the UK for Lemsip Max Cold & Flu Relief Capsules (PL 00063/0529) on 13 October 2009. The full PAR for Lemsip Max Cold & Flu Relief Capsules follows this summary. 3
For more information about treatment with Lemsip Max Cold & Flu Relief Capsules, read the package leaflet, or contact your doctor or pharmacist. This summary was last updated in November 2015. 4
LEMSIP MAX DAY & NIGHT COLD & FLU RELIEF CAPSULES (paracetamol, caffeine and phenylephrine hydrochloride) PL 00063/0529 SCIENTIFIC DISCUSSION TABLE OF CONTENTS Introduction Page 6 Pharmaceutical assessment Page 7 Non-clinical assessment Page 9 Clinical assessment Page 10 Overall conclusion and benefit/risk assessment and recommendation Page 11 5
SCIENTIFIC DISCUSSION I INTRODUCTION Based on the review of the data on quality, safety and efficacy the UK granted a Marketing Authorisation for the medicinal product Lemsip Max Day & Night Cold & Flu Relief Capsules (PL 00063/0529) to Reckitt Benckiser Healthcare (UK) Limited on 13 October 2009. The product consists of a Day Capsule and a Night Capsule. The Day Capsule is indicated for the relief of symptoms associated with the common cold and influenza including relief of aches and pains, sore throat, headache, fatigue and drowsiness, nasal congestion and lowering of temperature. The Night Capsule is intended for the same indications as the Day capsule minus fatigue and drowsiness, as expected from the lack of caffeine in this formulation. The Night Capsule is indicated for the relief of symptoms associated with colds and influenza including relief of aches and pains, sore throat, headache, lowering of temperature and the symptoms associated with nasal congestion to help allow sleep through relief of nasal congestion. The application was submitted pursuant to Article 10c of Directive 2001/83/EC, as amended, so called informed consent application. The reference medicinal product is Lemsip Max Day & Night Cold & Flu Relief Capsules (PL 00063/0143), which was granted to Reckitt Benckiser Healthcare (UK) Limited on 31 July 2006. The application is essentially for a duplicate Product Licence and the product will be marketed using the same product name as the reference product. A valid letter of informed consent and acknowledgement of access to the dossier of the reference medicinal product has been provided by Reckitt Benckiser. The legal category is Pharmacy medicine to differentiate between this and the reference product which is a GSL product. The pack sizes are different, being 16 capsules for the reference product and 24 capsules for this Product Licence. It is acceptable for two products to have the same brand name if the legal supply status is different. However, the two Marketing Authorisations must be identical in all respects but the pack size and no future divergence is permitted or a change in name of the divergent authorisation will be required. The active ingredients in the Day capsules are paracetamol (500mg), caffeine (25mg) and phenylephrine hydrochloride (6.1mg), whilst the Night capsules contain paracetamol (500mg) and phenylephrine hydrochloride (6.1mg). 6
PHARMACEUTICAL ASSESSMENT LICENCE NO: PL 00063/0529 PROPRIETARY NAME(S): Lemsip Max Day & Night Cold & Flu Relief Capsules ACTIVE(S): Paracetamol, caffeine and phenylephrine hydrochloride COMPANY NAME: Reckitt Benckiser Healthcare (UK) Limited E.C. ARTICLE: Article 10c of Directive 2001/83/EC, as amended LEGAL STATUS: P 1. INTRODUCTION This is a simple abridged application for Lemsip Max Day & Night Cold & Flu Relief Capsules (PL 00063/0529) submitted under Article 10c of Directive 2001/83/EC, as amended. The proposed Marketing Authorisation Holder is Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, East Yorkshire, United Kingdom. The application cross-refers to Lemsip Max Day & Night Cold & Flu Capsules (PL 00063/0143), which was originally authorised to Reckitt Benckiser Healthcare (UK) Limited on 31 July 2006. The current application is considered valid. 2. MARKETING AUTHORISATION APPLICATION FORM 2.1. Name The proposed name of the product is Lemsip Max Day & Night Cold & Flu Relief Capsules. The product has been named in line with current requirements. 2.2. Strength, pharmaceutical form, route of administration, container and pack sizes The active ingredients in the Day capsules are paracetamol (500mg), caffeine (25mg) and phenylephrine hydrochloride (6.1mg), whilst the Night capsules contain paracetamol (500mg) and phenylephrine hydrochloride (6.1mg). The finished product is packaged in unplasticised polyvinylchloride (upvc)/aluminium/paper blisters, in a pack size of 24 capsules. The proposed shelf-life (3 years) and storage conditions ( Do not store above 25 C. ) are consistent with the details registered for the cross-reference product. 2.3. Legal status On approval, the product will be available as a Pharmacy (P) medicine. 2.4. Marketing Authorisation Holder/Contact Persons/Company Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, East Yorkshire, United Kingdom. The Qualified Person (QP) responsible for pharmacovigilance is stated and a satisfactory CV has been provided. 2.5 Manufacturers The proposed manufacturing sites are consistent with the sites registered for the cross-reference product and evidence of Good Manufacturing Practice (GMP) compliance has been provided. 2.6. Qualitative and quantitative composition The proposed composition is consistent with the details registered for the cross-reference product. 7
2.7. Manufacturing process The proposed manufacturing process is consistent with the details registered for the cross-reference product and the maximum batch size is stated. 2.8. Finished product/shelf-life specification The proposed finished product specification is consistent with the details registered for the cross-reference product. 2.9. Drug substance specification The proposed drug substance specification is consistent with the details registered for the cross-reference product. 2.10. TSE Compliance The gelatin used in the capsule shell is derived from bovine sources and copies of relevant TSE certificates have been provided. With the exception of gelatin, no materials of animal or human origin are included in the product. This information is consistent with the cross-reference product 3. EXPERT REPORT The applicant has included detailed expert reports in Module 2 of the application. Signed declarations and copies of the experts CVs are enclosed in Module 1.4 for the quality, non-clinical and clinical experts. All are considered to have sufficient experience for their responsibilities. 4. PRODUCT NAME & APPEARANCE See Section 2.1 for details of the proposed product name. The appearance of the product is identical to the cross-reference product. 5. SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) The proposed SmPC is consistent with the details registered for the cross-reference product. 6. PATIENT INFORMATION LEAFLET (PIL) AND LABELLING PIL The patient information leaflet has been prepared in line with the details registered for the cross-reference product. The package leaflet has been submitted to the MHRA along with results of consultations with target patient groups ("user testing"), in accordance with Article 59 of Council Directive 2001/83/EC. The results indicate that the package leaflet is well-structured and organised, easy to understand and written in a comprehensive manner. The test shows that the patients/users are able to act upon the information that they contain. Carton and blister The proposed artwork is comparable to the artwork registered for the cross-reference product and complies with statutory requirements. In line with current legislation, the applicant has also included the name of the product in Braille on the outer packaging. 7. CONCLUSION The data submitted with the application is acceptable. The grant of a Marketing Authorisation is recommended. 8
NON-CLINICAL ASSESSMENT No new non-clinical data have been supplied with this application and none are required for an application of this type. The grant of a Marketing Authorisation is recommended. 9
CLINICAL ASSESSMENT No new clinical data have been supplied with this application and none are required for an application of this type. The grant of a Marketing Authorisation is recommended. 10
OVERALL CONCLUSION AND BENEFIT/RISK ASSESSMENT AND RECOMMENDATION QUALITY The data for this application is consistent with those previously assessed for the cross-reference product and as such, have been judged to be satisfactory. NON-CLINICAL No new non-clinical data were submitted and none are required for this type of application. EFFICACY This application is identical to a previously granted application of Lemsip Max Day & Night Cold & Flu Relief Capsules (PL 00063/0143), which was authorised to Reckitt Benckiser Healthcare (UK) Limited on 31 July 2006. SAFETY No new or unexpected safety concerns arose from this application. PRODUCT LITERATURE The SmPC and PIL are satisfactory, and consistent with those for the cross-reference product. The labelling complies with statutory requirements and is satisfactory. BENEFIT/RISK ASSESSMENT The quality of the product is acceptable and no new non-clinical or clinical safety concerns have been identified. The applicant s product is identical to the cross-reference product. Extensive clinical experience with paracetamol, caffeine and phenylephrine hydrochloride is considered to have demonstrated the therapeutic value of the compounds. The benefit/risk assessment is, therefore, considered to be positive. RECOMMENDATION The grant of a Marketing Authorisation is recommended. 11
SUMMARY OF PRODUCT CHARACTERISTICS In accordance with Directive 2010/84/EU, the Summaries of Product Characteristics (SmPCs) for products granted Marketing Authorisations at a national level are available on the MHRA website. 12
PATIENT INFORMATION LEAFLET In accordance with Directive 2010/84/EU, the Patient Information Leaflets (PILs) for products granted Marketing Authorisations at a national level are available on the MHRA website. 13
LABELLING The approved labelling for Lemsip Max Day & Night Cold & Flu Relief Capsules is presented below: 14
Lemsip Max Day & Night Cold & Flu Relief Capsules PL 00063/0529 15
16
LEMSIP MAX DAY & NIGHT COLD & FLU RELIEF CAPSULES (paracetamol, caffeine and phenylephrine hydrochloride) PL 00063/0529 STEPS TAKEN AFTER AUTHORISATION-SUMMARY The following table lists a non-safety update to the Marketing Authorisation for this product that has been approved by the MHRA since the product was first licensed. The table includes an update that has been added as an annex to this PAR. This is not a complete list of the post-authorisation changes that have been made to this Marketing Authorisation. Date submitted Application Scope type 22 January 2015 Type II To update sections 5.1 and 5.2 of the Summary of Product Characteristics (SmPC) to align with the Company Core Data Sheet (CCDS), following submission of the latest Periodic Safety Update Report (PSUR) for paracetamol, caffeine and phenylephrine hydrochloride. Outcome Approved on 04 September 2015 17
Annex 1 Our Reference: PL 00063/0529-0028 Product: Lemsip Max Day & Night Cold & Flu Relief Capsules Marketing Authorisation Holder: Reckitt Benckiser Healthcare (UK) Limited Active Ingredient(s): Paracetamol, phenylephrine hydrochloride and caffeine Type of Procedure: National Submission Type: Variation Submission Category: Type II Submission Complexity: Standard EU Procedure Number (if applicable): Not applicable Reason: To update sections 5.1 and 5.2 of the Summary of Product Characteristics (SmPC), to align with the Company Core Data Sheet (CCDS), following submission of the latest Periodic Safety Update Report (PSUR) for paracetamol, caffeine and phenylephrine hydrochloride. Linked / Related Variation(s) or Case(s): N/A Supporting Evidence Revised SmPC fragments and clinical overview. Evaluation The clinical overview and proposed changes to the SmPC are satisfactory. The clinical overview and updated SmPC fragments have been incorporated into the Marketing Authorisation. Conclusion The proposed changes to the clinical overview and SmPC are acceptable and there are no objections to approval. In accordance with Directive 2010/84/EU the Summaries of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs) for products granted Marketing Authorisations at a national level are available on the MHRA website Decision - Approved on 04 September 2015. 18